BEUDAMED
    FDA Enforcement Class II Terminated

    Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

    Recall: Z-0499-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0499-2013
    Event ID
    61209
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC dba Uni-Patch
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 19, 2012
    Initiation Date
    February 9, 2012
    Classification Date
    December 10, 2012
    Termination Date
    January 3, 2013
    Address
    1313 Grant Blvd W, N/A, Wabasha, MN, 55981-1058, United States

    Description

    Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

    Reason

    Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

    Code Info

    Lots 202404, 202506, 203431,

    Distribution

    Nationwide Distribution including CA, IL, MA, MN, and SD.

    Quantity

    3594 pouches